(101 days)
Not Found
No
The 510(k) summary describes a physical needle set for oocyte retrieval and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is used for obtaining oocytes, which is a procedure for assisted reproduction, not a therapeutic treatment for a disease or condition.
No
Explanation: The device is used for obtaining oocytes for assisted reproduction, which is a therapeutic or procedural action, not a diagnostic one. It retrieves a sample rather than providing information to diagnose a condition.
No
The device description explicitly states it is a "Needle Set," which is a physical, hardware component used for obtaining oocytes. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to obtain female gametes/oocytes from the body. This is a procedure performed on the patient, not a test performed on a sample taken from the patient to diagnose or monitor a condition.
- Device Description: The device is a needle set used for retrieval, not for analyzing a sample.
- Lack of IVD Characteristics: The description does not mention any analysis of a sample, detection of substances, or diagnostic purposes.
IVD devices are typically used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health status. This device is used to collect a sample from the body.
N/A
Intended Use / Indications for Use
The InnTec, Inc. Oocyte Retrieval Needle Set is an assisted reproduction needle indicated for used and intended to be used for obtaining female gametes/oocytes from the body.
Product codes
MQE
Device Description
The Oocyte Retrieval Needle Sets are sterile, single patient use, disposable devices supporting obtaining female gametes/oocytes from the body. The Oocyte Retrieval Needle Sets are packaged in a commercially available, sterile barrier pouch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.6100 Assisted reproduction needles.
(a)
Identification. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).
0
Page 1 of 2
K051742
OCT 7 - 2005
| Summary of Safety and Effectiveness | ||||||
|---|---|---|---|---|---|---|
| Company Name: InnTec, Inc. | ||||||
| 401 E. Edgewater St. | ||||||
| Portage, WI 53901 | ||||||
| Contact: Michael Kvalo, PE | ||||||
| Phone: 608 444-4544 | ||||||
| Fax: 608 846-6071 | ||||||
| Summary Date: June 23, 2005 | ||||||
| Trade Name: Oocyte Retrieval Needle Sets | ||||||
| Common Name: Assisted Reproduction Needle | ||||||
| Classification Name: 21 CFR ; Product Code: | ||||||
| Predicate Device: | ||||||
| 510(k) | Manufacturer | Product Code | Class | Trade Name | ||
| K992308 | Lifetek | |||||
| Medical, Inc. | MQE | II | Oocyte Retrieval Needle Set | |||
| 1.0 Description of Device | ||||||
| The Oocyte Retrieval Needle Sets are sterile, single patient use, disposable devices supporting obtaining female gametes/oocytes from the body. The Oocyte Retrieval Needle Sets are packaged in a commercially available, sterile barrier pouch. | ||||||
| 2.0 Intended Use | ||||||
| The InnTec, Inc. Oocyte Retrieval Needle Set is an assisted reproduction needle indicated for used and intended to be used for obtaining female gametes/oocytes from the body. | ||||||
| 3.0 Technology | ||||||
| The technology of the device is the same as the predicate. |
1
Page 2 of 2
K051742
Conclusions 4.0
Concesses of the manufacturing processes of the InnTec, Inc. Oocyte Retrieval Needle Sets are the same as the predicate device. No new questions of safety or effectiveness are raised.
2
Image /page/2/Picture/2 description: The image shows a logo with a stylized bird in flight. The bird is depicted with three thick, curved lines forming its body and wings. The logo is encircled by text, which appears to be part of the organization's name. The overall design is simple and abstract, focusing on the essence of a bird in motion.
OCT 7 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
InnTec, Inc. c/o Mr. Gary Syring Principal Consultant Ouality & Regulatory Associates, LLC 800 Levanger Lane STOUGHTON WI 53589
Re: K051742
Trade/Device Name: Oocyte Retrieval Needle Sets, Models 917-IH and 917-SH Regulation Number: 21 CFR §884.6100 Regulation Name: Assisted reproduction needles Regulatory Class: II Product Code: MQE Dated: August 30, 2005 . ત Received: August 31, 2005
Dear Mr. Syring:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally promated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): _ Kosj742 Device Name: Oocyte Retrieval Needle Sets Indications for Use:
The InnTec, Inc. Oocyte Retrieval Needle Set is an assisted reproduction needle indicated for used and intended to be used for obtaining female gametes / oocytes from the body.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Daniel A. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.